Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36) [ Time Frame: Baseline, 1-week posttreatment, and 5-week posttreatment. ] [ Designated as safety issue: No ]

Subjects' credibility to the treatment measured by Credibility of treatment rating scale [ Time Frame: Baseline, second treatment (expected 3-day post-baseline ) and the last time of the treatment (expected 19-day post-baseline ) ] [ Designated as safety issue: No ]

Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Other: Acupuncture

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Other Name: Electroacupuncture

Active Comparator: Minimal Acupuncture

Patients will be treated superficially at points away from classic acupoints. The points include bilateral "Forearm" [1 inch lateral to the middle point between HE3 and HE7] , "Upper arm" [1 inch lateral to LU 3 ], and "Lower leg" [0.5 inch dorsal to GB39]; for head, the non-acupoints include bilateral "Head" [middle point between GB8 and ST8], "Forehead" [middle point between ST8 and GB14], "Neck" [middle point between TB16 and SI17], and "Ear" [the point on the helix, inferior to the apex]. The points selected have been used in previous acupuncture studies as sham control. "De qi" is avoided during needling. The treatment procedure, electric-stimulation, frequency, duration and number of treatment sessions will be the same for the Traditional Acupuncture group.

Other: Acupuncture

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Other Name: Electroacupuncture

Placebo Comparator: Placebo Acupuncture

Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the site 1 inch beside the acupoints in order to avoid the acupressure effect. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.

Other: Acupuncture

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Other Name: Electroacupuncture

Detailed Description:

This is a randomized single-blinded controlled trial. Patients will be randomly assigned to one of the three groups. One is the traditional acupuncture treatment group, one is the non-traditional acupuncture treatment group and the other is an acupuncture-like placebo treatment. Patients will be put into groups and then compared. The chance of getting into each group is 2:2:1.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Aged 18 years or above

A previous Diagnostic and Statistical Manual of Mental Disorders-IV Major Depressive Disorder

Have a current Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of insomnia disorder

Have previous history of schizophrenia, other psychotic disorders, and bipolar disorder

Have current alcohol or drug abuse and dependence

Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception

Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe

Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study

Any acupuncture treatment during the previous 12 months prior to baseline and

Unstable medical conditions.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707706